Snigdha Bezawada, CCSA’s Regulatory Operations Manager, attended the LORENZlink User Conference, which covered a wide range of new topics concerning electronic Common Technical Document (eCTD) submissions. Highlights of the conference are given below.
Conference Summary Points
Upcoming eCTD v4.0:
During the conference, experts talked about how the new version varies from the current eCTD 3.2 version. Modifying the published submission will now only generate one single XML backbone, thus eliminating the Module 1 and US region XML backbone. With document re-use, document ordering, metadata corrections, two-way communication, and life-cycle capabilities, enhancements include using controlled vocabulary and creating a single format for node-extensions for all regions.
News & Tidbits
Health Canada will implement eCTD format for CTAs sometime in 2017 with the pilot program initiating at the end of the year 2016. The notice and requirement will be posted on Health Canada’s website sometime in Summer–Fall 2016.
Table Tutorials at the Lorenlink conference gave a business case scenario about the new US Module 1 Specifications and how to successfully submit regulatory submissions to FDA.
Electronic Common Technical Document (eCTD) v4.0: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm309911.htm